GLORIA-AF Registry Program (Phase I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01428765
First received: August 25, 2011
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

This study constitutes Phase I of the Registry Program. The main objective of this study is to characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-world setting before dabigatran etexilate is approved for the prevention of strokes and systemic emboli in patients with non-valvular AF in different regions of the world.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase I)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • CHADS2 Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).

  • CHA2DS2-VASc Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to "low risk", a score of 1 corresponds to "intermediate risk", and a score of 2 or more corresponds to "high risk".

  • HAS-BLED Risk Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.

  • Antithrombotic Treatment Choice at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gender [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Age Group [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Medical History [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 1096
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

cross-sectional

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients with non-valvular atrial fibrillation at risk for stroke

Criteria

Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation at risk for stroke.

Exclusion criteria:

  1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
  2. Patients who have received more than 60 days of oral anticoagulant treatment (vitamin K antagonist) (VKA) in their lifetime;
  3. Atrial fibrillation (AF) with a generally reversible cause;
  4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (VKAs) is indicated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428765

  Hide Study Locations
Locations
China
1160.114.08024 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08018 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08019 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08020 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08023 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08017 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08025 Boehringer Ingelheim Investigational Site
Beijing, China
1160.114.08007 Boehringer Ingelheim Investigational Site
Changsha, China
1160.114.08021 Boehringer Ingelheim Investigational Site
Dalian, China
1160.114.08006 Boehringer Ingelheim Investigational Site
Ghuangzhou, China
1160.114.08004 Boehringer Ingelheim Investigational Site
Ghuangzhou, China
1160.114.08002 Boehringer Ingelheim Investigational Site
Guangzhou, China
1160.114.08001 Boehringer Ingelheim Investigational Site
Guangzhou, China
1160.114.08005 Boehringer Ingelheim Investigational Site
Guangzhou, China
1160.114.08015 Boehringer Ingelheim Investigational Site
Hangzhou, China
1160.114.08011 Boehringer Ingelheim Investigational Site
Hangzhou, China
1160.114.08026 Boehringer Ingelheim Investigational Site
Nanjing, China
1160.114.08014 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.114.08027 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.114.08016 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.114.08010 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.114.08012 Boehringer Ingelheim Investigational Site
Shanghai, China
1160.114.08028 Boehringer Ingelheim Investigational Site
Shenzhen, China
1160.114.08022 Boehringer Ingelheim Investigational Site
Tianjin, China
1160.114.08008 Boehringer Ingelheim Investigational Site
Wuhan, China
Croatia
1160.114.04002 Boehringer Ingelheim Investigational Site
Krapinske Toplice, Croatia
1160.114.04001 Boehringer Ingelheim Investigational Site
Opatija, Croatia
1160.114.04003 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
1160.114.04004 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Egypt
1160.114.28001 Boehringer Ingelheim Investigational Site
Cairo, Egypt
Germany
1160.114.490216 Boehringer Ingelheim Investigational Site
Berlin, Germany
1160.114.490220 Boehringer Ingelheim Investigational Site
Berlin, Germany
1160.114.490201 Boehringer Ingelheim Investigational Site
Berlin, Germany
1160.114.490217 Boehringer Ingelheim Investigational Site
Dessau-Roßlau, Germany
1160.114.490214 Boehringer Ingelheim Investigational Site
Dinslaken, Germany
1160.114.490215 Boehringer Ingelheim Investigational Site
Halle, Germany
1160.114.490206 Boehringer Ingelheim Investigational Site
Itzehoe, Germany
1160.114.490209 Boehringer Ingelheim Investigational Site
Kempen, Germany
1160.114.490208 Boehringer Ingelheim Investigational Site
Ludwigsburg, Germany
1160.114.490212 Boehringer Ingelheim Investigational Site
Markkleeberg, Germany
1160.114.490207 Boehringer Ingelheim Investigational Site
Mühldorf, Germany
1160.114.490210 Boehringer Ingelheim Investigational Site
München, Germany
1160.114.490202 Boehringer Ingelheim Investigational Site
Northeim, Germany
1160.114.490204 Boehringer Ingelheim Investigational Site
Nürnberg, Germany
1160.114.490211 Boehringer Ingelheim Investigational Site
Wittenberg, Germany
Lebanon
1160.114.07001 Boehringer Ingelheim Investigational Site
Beirut, Lebanon
Netherlands
1160.114.31013 Boehringer Ingelheim Investigational Site
Deventer, Netherlands
1160.114.31008 Boehringer Ingelheim Investigational Site
Enschede, Netherlands
1160.114.31005 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
Spain
1160.114.34012 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1160.114.34004 Boehringer Ingelheim Investigational Site
Jaén, Spain
1160.114.34010 Boehringer Ingelheim Investigational Site
Madrid, Spain
1160.114.34005 Boehringer Ingelheim Investigational Site
Murcia, Spain
1160.114.34003 Boehringer Ingelheim Investigational Site
Málaga, Spain
1160.114.34013 Boehringer Ingelheim Investigational Site
Sabadell (Barcelona), Spain
1160.114.34011 Boehringer Ingelheim Investigational Site
Santiago de Compostela, Spain
1160.114.34006 Boehringer Ingelheim Investigational Site
Sevilla, Spain
1160.114.34001 Boehringer Ingelheim Investigational Site
Sevilla, Spain
Turkey
1160.114.09004 Boehringer Ingelheim Investigational Site
Adana, Turkey
1160.114.09001 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1160.114.09006 Boehringer Ingelheim Investigational Site
Antalya, Turkey
1160.114.09009 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01428765     History of Changes
Other Study ID Numbers: 1160.114
Study First Received: August 25, 2011
Results First Received: January 21, 2014
Last Updated: January 21, 2014
Health Authority: China: Food and Drug Administration
Croatia: Agency for Medicinal Product and Medical Devices
Egypt:
Germany: Ethics Commission
Lebanon:
Netherlands:
Spain:
Turkey: Ministry of Health
United Arab. Emirates:

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014